Application 212265

Type: ANDA
Sponsor: MSN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DECITABINE	DECITABINE	INJECTABLE;INTRAVENOUS	50MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212265-001	DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP		2019-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212265-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212265-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212265-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212265-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212265-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212265-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212265-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212265-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212265-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212265-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212265-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212265-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212265-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212265-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212265-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212265-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212265-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212265-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212265-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212265-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212265-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212265-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212265-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212265-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212265-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212265-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212265-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212265-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212265-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212265-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212265-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212265-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212265-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212265-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212265-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212265-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212265-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212265-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212265-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212265-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212265-001	AP	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Decitabine	DECITABINE	Bryant Ranch Prepack	c731a9f0-46ee-41c3-8f89-179cab13bdd2	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265
Decitabine	DECITABINE	Novadoz Pharmaceuticals LLC	a1b43089-bc88-4ac6-bdee-9cc38ec30f4e	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265 ndc (product): 72205-036
Decitabine	DECITABINE	Northstar Rx LLC	1abbe952-58bc-4dbc-b06a-fb79167bcd66	2020-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265 ndc (product): 72603-107
Decitabine	DECITABINE	Novadoz Pharmaceuticals LLC	ae6c4580-3a3a-4c42-903a-1565d79521f8	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265 ndc (product): 72205-031

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3296	Decitabine	Decitabine	Sandoz Inc	ANDA	Current
0781-3296	Decitabine	Decitabine	Sandoz Inc	ANDA	Current
69539-115	Decitabine	Decitabine	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-115	Decitabine	Decitabine	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
72205-031	Decitabine	Decitabine	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-031	Decitabine	Decitabine	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-036	Decitabine	Decitabine	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-036	Decitabine	Decitabine	Novadoz Pharmaceuticals LLC	ANDA	Current
72603-107	Decitabine	Decitabine	Northstar Rx LLC	ANDA	Current